This study compares aripiprazole once-monthly injection to standard of care oral antipsychotic medication in non-adherent outpatients with schizophrenia to see which treatment helps people take their medicine more regularly and have more positive outcomes. It is hypothesized that non-adherent schizophrenia outpatients receiving aripiprazole once-monthly will be more likely to respond and have lower symptom severity over 3 months of treatment than those receiving standard of care oral antipsychotics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
Oral antipsychotic medication
UT Southwestern Medical Center
Dallas, Texas, United States
RECRUITINGEfficacy: PANSS (Positive and Negative Syndrome Scale) total score improvement - response
PANSS total score - operationalized as a binary response, defined as at least a 20% improvement in PANSS totals core, from the three monthly visits.
Time frame: from date of randomization up to 3 months
Efficacy: PANSS total score overall - symptom severity
PANSS total score - continuous, from the three monthly visits
Time frame: from date of randomization up to 3 months
Quality of Life
Schizophrenia Quality of Life Scale (SQLS)
Time frame: from date of randomization up to 3 months
Cognition
Brief Assessment of Cognition in Schizophrenia (BACS)
Time frame: from date of randomizatino up to 3 months
Substance Use
Alcohol Use Scale (AUS) and Drug Use Scale (DUS)
Time frame: from date of randomization up to 3 months
Safety assessed by Treatment-emergent adverse events (TEAEs), physical examination including vital signs, clinical laboratory testing including prolactin and lipid profiles, and the Columbia Suicide Severity Rating Scale (C-SSRS)
Treatment-emergent adverse events (TEAEs), physical examination including vital signs, clinical laboratory testing including prolactin and lipid profiles, and the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: from date of randomization up to 3 months
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